Sr Engineer I, Manufacturing Sciences

Biogen; North Carolina; On-site; USD 98,000 - 127,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Wellness Program

Disability Insurance

Paid vacation

Holiday time off

Equity incentive

Cash bonus

Job summary

Biogen seeks a Senior Engineer I, Manufacturing Sciences to provide SME expertise across end-to-end single-use consumable raw materials from Drug Substance to Drug Product fill. You will collaborate with suppliers, sites, and regulatory teams to ensure materials are fit for use and compliant with evolving regulations.

The hybrid role includes on-site presence during inspections and vendor audits, with responsibilities spanning deviations, CAPAs, technical risk assessments, and regulatory filings

Qualifications

• Bachelor's degree in relevant scientific or technical field.
• 4+ years of directly relevant industry experience.
• Strong analytical skills to evaluate plastics and single-use technologies.
• Knowledge of polymers, chemistry, and single-use systems for biopharma manufacturing.
• Experience supporting deviations, change controls, CAPAs, and regulatory docs.
• Root cause analysis and risk-based assessments experience.
• Willingness to work on-site during training/critical projects/audits.

Responsibilities

• Serve as SME for single-use raw materials and supplier capabilities across the global network.
• Support development and implementation of raw material control strategies.
• Lead continuous improvement initiatives for raw materials and supplier audits.
• Conduct investigations with laboratory experiments and supplier data.
• Troubleshoot single-use material failures and assess process impact.
• Perform risk assessments for VCNs and NIRs including E/L impact.
• Own and support global extractables/leachables studies and regulatory alignment.
• Participate in industry forums and external collaborations.
• Support inspections, vendor audits, and regulatory filings.

Skills

Analytical skills

Problem solving

Regulatory documentation familiarity

Extractables & Leachables knowledge

Single-use systems knowledge

Polymeric materials knowledge

Cross-functional collaboration

On-site readiness

Education

Bachelor's degree in a relevant scientific or technical field

Tools

None

Job description

About this role

The Senior Engineer I, Manufacturing Sciences is a key technical contributor providing subject matter expertise across end-to-end single-use consumable raw materials, from Drug Substance through Drug Product fill. This role supports the Process Optimization & Technology (PO&T) organization by assessing raw material changes, deviations, CAPAs, and regulatory documentation, while serving as the Subject Matter Expert (SME) of extractables and leachables (E/L) program assessments.

The position partners closely with suppliers, manufacturing sites, and regulatory teams to ensure materials are fit for use, compliant with evolving global regulations, and capable of supporting both current and future manufacturing needs. This is a hybrid role with on-site presence required during inspections and vendor audits.

What you'll do

• Serve as a technical Subject Matter Expert (SME) for single-use consumable raw materials, supplier capabilities, control strategies, and manufacturing needs across the global manufacturing network
• Support development and implementation of raw material control strategies and monitoring technologies to enable incoming material release
• Lead continuous improvement initiatives related to raw materials, including technical support for new item requests and supplier audits
• Conduct investigations by performing laboratory experiments, gathering supplier data, developing historical trends, and assessing lot usage
• Troubleshoot single-use material failures (e.g., filter integrity test failures), perform root cause analyses, and evaluate potential process impacts
• Perform technical risk assessments for Vendor Change Notifications (VCNs) and New Item Requests (NIRs), including chemical compatibility, stability, thermal properties, and extractables/leachables impact
• Own and support global extractables/leachables studies, ensuring alignment with current global regulatory guidance
• Participate in industry forums and external E/L collaborations to advance best practices
• Support internal and agency inspections, vendor audits, and regulatory filings related to raw materials and single-use technologies

Who you are

You are a technically curious and analytical engineer who enjoys solving complex manufacturing challenges and collaborating across functions. You work independently, proactively identify improvements, and are comfortable serving as a technical leader within your area of expertise.

Required skills

• Bachelor's degree in relevant scientific or technical fields from an accredited college or university
• At minimum 4 years of directly relevant industry or industry-adjacent experience
• Proven scientific and analytical skills to evaluate suitability of plastics and single-use technologies across multiple manufacturing modalities
• Knowledge of polymeric materials, chemistry, and single-use systems for biopharmaceutical manufacturing
• Experience supporting deviations, change controls, CAPAs, and regulatory documentation
• Previous experience performing root cause analysis and risk-based technical assessments
• Willingness and ability to work on-site more frequently during training periods, critical projects, audits, etc.

Preferred skills

• Bachelor's degree in engineering, chemistry, materials science, or a related technical field from an accredited college or university
• Hands‑t experience with extractables and leachables studies and regulatory expectations
• Familiarity with single‑use systems, container closure systems, and supplier change management
• Experience supporting regulatory inspections and vendor audits
• Prior experience acting as a technical lead or SME within a manufacturing or engineering organization
• Participation in industry forums, external collaborations, or technical working groups related to E/L or single-use technologies
• Previous experience partnering with external contractors and vendors

Job Level: Professional

Additional Information

The base compensation range for this role is: $98,000.00-$127,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well‑being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid da